BOND APATITE— 510(k) K121177

Substantially Equivalent

Augma Biomaterials, Ltd.

FDA 510(k) clearance K121177 for BOND APATITE, Substantially Equivalent on 2013-12-05. Applicant: Augma Biomaterials, Ltd.. Device class: 2.

Clearance details

Applicant: Augma Biomaterials, Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2012-04-18
Decision date: 2013-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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